NCT07600476 A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors
| NCT ID | NCT07600476 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Kupando GmbH |
| Condition | Cutaneous Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2026-07-03 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 21 participants in total. It began in 2026-07-03 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this trial is to find the maximum tolerated and recommended Phase 2 dose of KUP-101A and to evaluate its safety and tolerability. Additionally, pharmacokinetics and pharmacodynamics will be assessed, and first data on KUP-101A's efficacy in patients with advanced solid tumors will be obtained.
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed cancer with evidence of advanced disease for which no other standard treatment is available * ECOG Performance status of 0 to 2 * Adequate hematological, renal, and hepatic organ function Exclusion Criteria: * Previous systemic treatment with TLR agonists, with the exception of TLR agonists used as vaccine adjuvants. * Known additional malignancy that is progressing or requires active treatment * Diagnosis of immunodeficiency * Active autoimmune disease not caused by prior anticancer treatment that required systemic immunosuppressive treatment in the past 2 years * Active autoimmune disease caused by prior anticancer treatment, unless currently controlled by replacement therapy only. * Any kind of leukemia * Previously received an organ transplant (other than corneal transplants) or hematopoietic stem cell transplantation * Known active central nervous system metastases and/or carcinomatous meningitis * Cerebral vascular event within 6 months before Screening * Unstable cardiopulmonary status defined by uncontrolled congestive heart failure of New York Heart Association Grade III or IV, unstable angina, or myocardial infarction within 6 months before Screening * High grade ocular disease such as uncontrolled glaucoma
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07600476 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cutaneous Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07600476 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07600476 currently recruiting?
Yes, NCT07600476 is actively recruiting participants. Contact the research team at clinicaltrials@kupando.com for enrollment information.
Where is the NCT07600476 trial being conducted?
This trial is being conducted at Munich, Germany, Würzburg, Germany, Münster, Germany.
Who is sponsoring the NCT07600476 clinical trial?
NCT07600476 is sponsored by Kupando GmbH. The trial plans to enroll 21 participants.
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